Durable Viral Suppression among HIV Care Coordination Participants and Nonparticipants

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2 Durable Viral Suppression among HIV Care Coordination Participants and Nonparticipants McKaylee Robertson, 1 Kate Penrose, 2 Mary Irvine, 2 Rebekkah Robbins, 2 Sarah Kulkarni, 1 Sarah Braunstein, 2 Levi Waldron, 1 Graham Harriman, 2 Denis Nash Institute for Implementation Science in Population Health (ISPH), Graduate School of Public Health and Health Policy, City University of New York (CUNY) New York City Department of Health and Mental Hygiene

3 Conflict of Interest Disclosure McKaylee Robertson Has no real or apparent conflicts of interest to report.

4 HIV Care Coordination in NYC In 2009, with Ryan White Part A funding, NYC began implementing a comprehensive HIV care coordination program (CCP) at 28 HIV care provider agencies Targets patients at high risk for suboptimal outcomes The CCP intervention combines various evidence-based programmatic elements*: Case conferencing, patient navigation, adherence support including directly observed therapy (DOT), structured health promotion, and case conferencing Service delivery program no randomization CCP increases short-term (12 month) viral load suppression, beyond usual care, for Persons newly diagnosed or Persons with no evidence of viral suppression 12 months prior to enrollment *For more details, see CDC s Compendium of Evidence-Based Interventions:

5 Objective We aimed to compare durable viral suppression (DVS) of CCP enrollees with DVS in a matched group of HIV patients for 24 months, following an initial 12-month period for establishment in care and treatment. Enrollment End of Follow Up 0 Months Month Durable Viral Suppression Monitoring

6 Data Sources We retrospectively created an observational cohort of persons enrolled and not enrolled in the CCP by merging Provider-reported programmatic data (CCP clients) NYC HIV Surveillance Registry data (NYC residents with diagnosed HIV) Persons not enrolled in the CCP were identified after the merge and considered to be in the usual-care group For CCP and non-ccp persons, all outcome data (viral load) was taken from the Registry

7 Matched Usual-Care Comparison Randomly assigned a pseudo-enrollment date to usual-care Matched CCP enrollees to those in the usual-care group on Propensity for CCP enrollment, Pseudo-enrollment/enrollment dates and Baseline treatment status Baseline Treatment Newly diagnosed Consistently suppressed No evidence of suppression Definition Diagnosed 12 months prior to pseudoenrollment/enrollment 2 VLs 90 days apart and all VLs 200 copies/µl All VLs reported >200 copies/µl or no VL reported Inconsistently suppressed 1 VL 200 copies/µl but not all VLs 200 copies/µl

8 Statistical Analysis and Outcome Definitions Durable viral suppression (DVS): Regular monitoring: 1 VL result in each 12-month period of follow-up All VLs 200 copies/µl From months of follow-up Also examined DVS using a 1500 copies/µl threshold Ever achieved viral load suppression: 1 VL was 200 copies/µl From 0-36 months of follow-up To examine DVS, used log binomial regression

9 Characteristics of Matched CCP and Usual-Care Persons CCP-Enrollees N = 7,058 12/09 to 3/13 Long-Term NYC Residents* N = (90%) Matched CCP N = 6,284 (89%) Characteristic CCP N (%) Usual Care N (%) Total (N = 12,414) 6,207 (100) 6,207 (100) Male 3,955 (64) 3,951 (64%) Black 3,322 (54) 3,414 (55) ,596 (42) 2,576 (42) Men who have sex with men 1,788 (29) 1,810 (29) Baseline CD4 < (32) (31) * 1 VL in first 12 months and 2 VL in months of enrollment

10 Durable Viral Suppression (%) CCP versus Usual Care, by Baseline Treatment Status CCP Usual Care RR = 0.97 (0.93, 1.03) RR = 1.02 (0.93, 1.11) RR = 1.16 (1.04, 1.29) RR = 0.87 (0.79,0.95) Total (100%) Newly Diagnosed (15%) No Evidence of Viral Suppression (41%) Inconsistent Viral Consistent Viral Suppression (29%) Suppression (15%)

11 Viral Load Ever 200 or DVS at 1500 and 200 Copies/µL Thresholds (%) CCP versus Usual Care CCP Usual Care VL Ever 200 DVS 1500 DVS 200

12 Strengths Outcome data for CCP and usual-care group was longitudinal and came from the same source, and available regardless of care location or duration of enrollment 3 years of follow-up Ability to examine different viral load outcome definitions Population-based comparison group Our method of creating a comparison group (i.e., matching on pseudo-enrollment/enrollment date) ensured a CCP effect was not the result of secular improvements in VLS

13 Observational study Limitations Possibility of uncontrolled confounding remains However, we controlled for numerous demographic and clinical confounders, in addition to secular trends in VLS Change in treatment guidelines may affect outcomes of persons with high pre-treatment CD4 counts (>500 cells)

14 Discussion (1) Consistent with our short-term outcomes, CCP effect among persons with no evidence of viral suppression, the largest group of enrollees by baseline status New York has many care and treatment services available to PLWH People in usual-care group may be receiving similar services as CCP-enrollees CCP effect may look better in jurisdictions with fewer resources No CCP effect for newly diagnosed Newly diagnosed are entering a more favorable treatment landscape (e.g., reduced toxicity) with fewer negative experiences around ART and more services available than previous generations As a result, newly diagnosed persons may have an easier time achieving DVS

15 Discussion (2) CCP enrollees have more observation time and VL events reported during follow-up than the usual-care group As a result, CCP group had more opportunities to fail on our measure of DVS than the usual-care group Most problematic for outcomes measured among CCPenrollees in the inconsistently suppressed group Because the inconsistently suppressed group is, by definition, moving above and below the 200 copies/ul threshold Proportion achieving DVS is very low (36%) Almost everyone had access to ART (90% ever suppressed). Implies the barrier to achieving DVS is ART adherence over time, and not access to care

16 Acknowledgements CHORDS Study team Care Coordination Program Service Providers and Clients DOHMH CCP TA providers Bruce Levin, PhD (Columbia University) This work was supported through a grant from the Health Resources and Services Administration (H89HA00015) and a grant from NIMH (1R01MH101028) entitled HIV care coordination: comparative effectiveness, outcome determinants and costs (the CHORDS study).

17 Supplemental Slides

18 Supplemental Background

19 Short Term - Viral Suppression (%) at 12 Months after Enrollment CCP versus Usual Care, by Baseline Treatment Status CCP Usual Care RR = 1.01 (0.98, 1.04) RR = 1.15 (1.09, 1.23) RR =1.32 (1.23, 1.42) RR = 0.99 (0.95, 1.05) Newly Diagnosed No Evidence of Viral Suppression Inconsistent Viral Suppression Consistent Viral Suppression

20 Supplemental Methods

21 Data Sources NYC HIV Registry** All diagnosed PLWH in NYC CCP Clients (eshare*) CCP Clients (Registry) Non-CCP comparison group Outcome information (longitudinal CD4 counts and viral loads) *Electronic System for HIV/AIDS Reporting and Evaluation (eshare) **The NYC HIV Registry contains information on HIV diagnoses and longitudinal viral load results for all diagnosed persons living with HIV.

22 Constructing a Usual-Care Comparison (1) 1. Identified persons who met clinical criteria for CCP enrollment, but were not enrolled 1. Newly diagnosed 2. Out of medical care 3. Treatment naïve 4. Exhibiting poor ART adherence 5. Experiencing a viral rebound 6. Experiencing a high viral load N = 62,828 Eligible Persons

23 Constructing a Usual-Care Comparison (2) 2. Randomly assigned a pseudoenrollment date to eligible persons and restricted to persons residing in NYC Assigned with probabilities such that the temporal distribution of dates matched the distribution of enrollment dates among CCP enrollees Pseudo-enrollment date = time zero Required persons to have 1 VL in months 0-12 after pseudoenrollment/enrollment and 2 VLs in months (evidence of NYC residence and HIV care) N = 62,828 Eligible Persons N = 37,108 Assigned pseudo -enrollment date and residing in NYC

24 Constructing a Usual-Care Comparison (3) 3. Matched CCP enrollees to those in the usual-care group on a) Propensity for CCP enrollment b) Pseudo-enrollment/enrollment dates c) Baseline treatment status Baseline Treatment Status Definition Newly diagnosed Consistently suppressed No evidence of suppression Diagnosed 12 months prior to pseudoenrollment/enrollment 2 VLs 90 days apart and all VLs 200 copies/µl All VLs reported >200 copies/µl or no VL reported Inconsistently suppressed 1 VL 200 copies/µl, but not all VLs 200 copies/µl

25 Supplemental Results

26 Viral Load Ever 200 (%) CCP versus Usual Care, by Baseline Treatment Status CCP Usual Care RR = 1.03 RR = 1.02 (1.02, 1.04) (0.99, 1.04) RR = 1.07 (1.04, 1.10) RR = 1.00 (0.99, 1.03) RR = 1.00 (0.99, 1.00) Total (100%) Newly Diagnosed (15%) No Evidence of Viral Suppression (41%) Inconsistent Viral Consistent Viral Suppression (29%) Suppression (15%)

27 Long Term Durable Viral Suppression at 1500 copies/µl threshold (%) CCP versus Usual Care, by Baseline Treatment Status CCP Usual Care RR = 1.00 (0.97, 1.03) RR = 1.05 (0.99, 1.04) RR = 0.87 (0.83, 0.93) RR = 0.99 (0.96, 1.04) RR = 1.12 (1.03, 1.23) Total (100%) Newly Diagnosed (15%) No Evidence of Viral Suppression (41%) Inconsistent Viral Consistent Viral Suppression (29%) Suppression (15%)

28 Proportion with Durable Viral Suppression at 200 copies/µl threshold (%), by Length of Enrollment - Among CCP Enrollees Always Suppressed No Evidence of Viral Suppression Inconsistent Viral Suppression Newly Diagnosed 0-91 days days days >365 days

29 Proportion with Durable Viral Suppression at 200 copies/µl threshold (%), by Year of Enrollment and CD4 count at enrollment - Among Newly Diagnosed CCP Enrollees <200 % DVS / Year of Enrollment in Program

30 Differences in Person-Time and Number of Laboratory Results CCP Versus Usual Care Mean (STD) Total PT CCP Mean (STD) Total PT Non- CCP P-value paired t- test Mean (STD) Total Labs CCP Mean (STD) Total Labs Non-CCP P-value paired t- test Baseline - Match Groups Newly Diagnosed (127.8) (146.3) (2.3) 5.7 (2.1) < Always Suppressed (112.5) (134.5) < (2.1) 5.7 (2.2) < Never Suppressed (147.5) (160.6) < (3.1) 6.3 (2.9) < Inconsistently Suppressed (138.5) (146.2) (3.0) 6.3 (2.7) < Person-time: number of days from first to last laboratory even reported in months of follow-up Total labs: number of CD4 or VL laboratory results reported to surveillance in months of follow-up

31 Time above 1500 copies/µl (days) CCP versus Usual Care, by Baseline Treatment Status Mean (STD) Days CCP Mean (STD) Days Non-CCP P-value paired t- test Baseline - Match Groups Newly Diagnosed 92.1 (175.7) 96.4 (173.2) 0.59 Always Suppressed 33.2 (103.0) 28.5 (92.4) 0.3 Never Suppressed (226.4) (227.3) 0.15 Inconsistently Suppressed (200.7) (190.3) Time above 1500 copies/ul: Marks, Gary, et al. "Time above 1500 copies: a viral load measure for assessing transmission risk of HIV-positive patients in care." AIDS (London, England) 29.8 (2015): 947.

32 Year of Diagnosis (%) by Baseline Treatment Status among Matched Population Diagnosed >1 Year before Pseudo- Enrollment/Enrollment Year of HIV Diagnosis No Evidence of Viral Suppression Inconsistent Viral Suppression Consistent Viral Suppression N = 5,084 N = 3,644 N = 1,850 Prior

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